Topics ICH Prague Meeting" was held.

Printable PDF

The International Conference on Harmonization of Pharmaceutical Regulations (ICH) for the second half of 2023 was held in Prague (Czech Republic) from October 28 to November 1. Although participation in the meeting was again in principle by face-to-face meetings, the establishment of web conferencing continued to operate as in the past in case of unavoidable circumstances, such as travel or health reasons.

Overall Photo Overall Photo

At this meeting, the Management Committee, which is responsible for the management of the ICH and preparation of proposals to be made and discussed at the General Assembly, and the General Assembly, in which all members participate, were held. In addition, the 16 expert working groups that will discuss the technical guidelines were also held in parallel during the same period to make progress in developing the ICH guidelines.

Participating organizations at the Prague meeting included 6 industry-government organizations*1 from Japan, the U.S., and the EU, which are founding members, 2 permanent member organizations (Health Canada and Swissmedic), 13 member organizations*2, 2 permanent observers*3, and 21 observers. More than 500 participants from around the world attended the meeting in Prague, and 35 people from the Pharmaceutical Manufacturers Association of Japan (PMAJ) participated on-site, including experts from the Expert Working Group.

Below are some special notes based on the ICH Management Committee and ICH General Assembly in Prague.

1

U.S. Food and Drug Administration (FDA), European Commission/European Medicines Agency (EC/EMA), Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Manufacturers and Associations (EFPIA), Pharmaceutical Manufacturers Association (JPMA)
2.

Brazil's National Agency for Health Supervision (ANVISA), Korea's Ministry of Food and Drug Safety (MFDS), China's National Medicines Supervision Administration (NMPA), Singapore's Health Sciences Authority (HSA), Taiwan's Food and Drug Administration (TFDA), Turkey's Pharmaceutical and Medical Devices Agency (TITCK), Saudi Arabia's Food and Drug Administration (SFDA), Mexico's Federal Commission for Sanitary Risk Control (COFEPRIS), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Egyptian Medicines Agency (EDA), the Biotechnology Innovation Institute (BIO), the International Generic and Biosimilar Pharmaceuticals Association (IGBA), the Global Self-Care Federation (GSCF), the
3

World Health Organization (WHO), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

1. new members and observers

Although no organization applied for membership, the Hong Kong regulatory authority (Pharmaceuticals and Poisons Board of Hong Kong, PPBHK) applied for membership as a new ICH observer, which was approved at the ICH Plenary Meeting.

As a result, ICH now has 21 member organizations and 37 observer organizations, bringing the total number of ICH members to 58 (see reference material at the end of this report).

2. trends in ICH technical topics

During the Prague meeting, progress was made through active discussions in all 16 topic working groups.

Working Groups with Meetings

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q1/Q5C EWG: Revision of "Guidelines for stability testing of pharmaceutical products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q2 (R2)/Q14 EWG: Revision of "Analytical Method Validation" and "Analytical Method Development
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q3E EWG: Evaluation and Control of Eluates and Exudates of Pharmaceutical and Biological Products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q5A (R2) EWG: Revision of "Viral Safety Assessment Guidelines for Biotechnology-applied Pharmaceuticals and Other Products Produced Using Human or Animal Cell Lines
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Q9 (R1) IWG: Revision of "Guidelines for Quality Risk Management
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E2B (R3) EWG/IWG: Revision of "Data Items and Message Specifications for Individual Case Safety Report (ICSR)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E6 (R3) EWG: Revision of "Standards for the Conduct of Clinical Trials of Pharmaceutical Products
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E11A EWG: Extrapolation in Pediatric Drug Development
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E20 EWG: Adaptive Clinical Trials
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	E21 EWG: Inclusion of Pregnant and Lactating Women in Clinical Trials
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M1PtC WG: ICH International Drug Terminology (MedDRA)
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M4Q(R2)EWG: Revision of Common Technical Documents - Guidelines for Quality Documentation
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M11 EWG: Electronically Structured and Harmonized Clinical Trial Protocols
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M12 EWG: Drug Interaction Studies
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M13 EWG: Bioequivalence Studies for Immediate Release Oral Solid Dosage Forms
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	M15 EWG: General Principles for Model-Informed Drug Development

At the Prague meeting, the ICH General Assembly approved Q2(R2) "Guidelines for Validation of Analytical Methods," Q14 "Guidelines for Development of Analytical Methods," and Q5A(R2) "Guidelines for Viral Safety Assessment of Biotechnology-based Pharmaceuticals Produced Using Human or Animal Cell Lines, (Reaching Step 4 means that the final English version of the guideline has been finalized and is now in the process of being implemented by regulatory authorities.)

ICH Awards

The ICH Award was established in 2022 to recognize experts who have demonstrated leadership and made significant contributions to the development of the ICH Guidelines. From Japan, one was selected from the regulatory side and one from the industry side. From the industry side, Mr. Shigeru Hisada, a safety domain expert from the Pharmaceutical Manufacturers Association of Japan (formerly of the Committee for Drug Evaluation), received the award for his important leadership and sustained contributions to the ICH Expert Working Groups.

Election of Chair and Vice-Chair of ICH General Assembly/Management Committee

With the expiration of the terms of the Chair and Vice-Chair of the ICH General Assembly and Management Committee, elections were held at the Prague meeting. As a result of the election, Mr. Naoyuki Yasuda, Executive Officer of PMDA, was re-elected as Vice-Chair of the ICH Management Committee.

ICH General Assembly:	Chair Ms. Lenita Lindström (EC) Vice-Chair Ms. Gabriela Zenhaeusern (Swissmedic)
ICH Management Committee:	Chair Ms. Theresa Mullin (FDA) Vice Chair Mr. Naoyuki Yasuda (MHLW/PMDA)

Next ICH Meeting

The meeting is scheduled to be held in Fukuoka, Japan from June 1 to 5, 2024.

ICH actively discloses information on ICH activities, including the outcomes of ICH meetings, to deepen understanding of ICH activities among the general public as well as the relevant parties. The outcomes of the ICH Prague meeting, as well as concept papers and work plans for each topic, are available on the ICH website ( https://www.ich.org/ ).